Engaging Informal Health Care Providers on Case Detection and Treatment Initiation Rates for TB and HIV in Rural Malawi (Triage Plus)

Liverpool School of Tropical Medicine

Status: Completed

Conditions: Tuberculosis; HIV

Treatments: Behavioral: Delayed intervention; Behavioral: Early intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT02127983

TriagePlus

Details and patient eligibility

About

The intervention consisted of training non-paid informal healthcare providers (such as store-keepers) in TB and HIV disease recognition, sputum specimen collection, referral to the public health system, and raising community awareness. Front line public health personnel and community leaders were sensitised to support the intervention.

Full description

A phased, matched, parallel cluster design was used to randomise three clusters (average population size per cluster = 200,714) to the Early intervention arm (received the intervention early in the first 12 months) and an equal number to the Delayed intervention arm (average population size per cluster = 209,564) which received the intervention after one year. Data for impact evaluation were obtained from routine patient registers in all the health facilities and patients were blindly allocated to the respective clusters based on residential address. Treatment initiation rates (expressed as incidence rate ratios) for TB and Anti Retroviral Therapy (ART) over the 12 months period were the primary outcome measures for each of the studied conditions. Poisson regression models with robust standard errors were used to assess the effectiveness of the intervention.

Enrollment: 200,000 patients

Sex: All

Ages: 16+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• People accessing informal providers with possible TB or HIV

Exclusion criteria

• children
• people already with a diagnosis of TB or HIV

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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200,000 participants in 2 patient groups

Early intervention

Experimental group

Description:

Early intervention arm engaging informal providers Received the intervention early in the first 12 months

Treatment:

Behavioral: Early intervention

Delayed intervention

Active Comparator group

Description:

Delayed intervention arm, engaging informal providers Received the intervention after one year

Treatment:

Behavioral: Delayed intervention